Table 1.
Baseline characteristics
| Characteristic | Number (%), median (range) |
||
|---|---|---|---|
| Dose level 1, 100 mg daily (n = 10) | Dose level 2, 100 mg twice daily (n = 10) | Total (n = 20) | |
| DLBCL | 8 (80) | 7 (70) | 15 (75) |
| HGBCL | 1 (10) | 0 (0) | 1 (5) |
| PMBCL | 0 (0) | 1 (10) | 1 (5) |
| TFL | 1 (10) | 2 (20) | 3 (15) |
| Age (y) | 60 (39-81) | 58 (26-81) | 58 (26-81) |
| Age > 60 y | 5 (50) | 5 (50) | 10 (50) |
| Male | 6 (60) | 10 (100) | 16 (80) |
| ECOG performance status ≥ 1 | 3 (30) | 5 (50) | 8 (40) |
| Ann Arbor stage III-IV | 10 (100) | 9 (90) | 19 (95) |
| Extranodal sites > 1 | 3 (30) | 6 (60) | 9 (45) |
| International Prognostic Index score ≥ 3 | 7 (70) | 7 (70) | 14 (70) |
| Absolute neutrophil count, 109/L | 3 (1.4-9.7) | 3.7 (1.3-8.9) | 3.3 (1.3-9.7) |
| Absolute lymphocyte count, 109/L | 0.7 (0.3-1.1) | 0.4 (0.2-2.3) | 0.6 (0.2-2.3) |
| Absolute monocyte count, 109/L | 0.6 (0.2-2) | 0.6 (0.3-1.2) | 0.6 (0.2-2) |
| Hemoglobin, g/dL | 11.6 (8.3-13.8) | 11.6 (6.3-14.7) | 11.6 (6.3-14.7) |
| Platelet count, 109/L | 149 (90-231) | 115 (71-362) | 144 (71-362) |
| C-reactive protein, mg/L | 8.2 (0.7-63) | 10.4 (0.4-79) | 8.6 (0.4-79) |
| Ferritin, mg/L | 277 (20-3190) | 300 (58-1520) | 300 (20-3190) |
| Lactate dehydrogenase, U/L | 250 (200-348) | 302 (144-756) | 268 (144-756) |
| Lactate dehydrogenase > UNL | 7 (70) | 8 (80) | 15 (75) |
| Creatinine clearance, mL/min | 79 (64-105) | 80 (40-127) | 80 (40-127) |
| Previous therapies | 4 (2-8) | 3 (2-5) | 3 (2-8) |
| Bridging therapy use | 5 (50) | 7 (70) | 12 (60) |
| Bridging | |||
| Chemotherapy | 2 (20) | 2 (20) | 4 (20) |
| Radiation therapy | 1 (10) | 4 (40) | 5 (25) |
| Biological therapy | 2 (10) | 1 (10) | 3 (15) |
| Refractory disease | 10 (100) | 10 (100) | 20 (100) |
| Previous autologous SCT | 0 (0) | 1 (10) | 1 (5) |
| Previous allogeneic SCT | 0 (0) | 0 (0) | 0 (0) |
| Total metabolic tumor volume, mL | 25 (6-85) | 38 (3-226) | 31 (3-226) |
DLBCL, diffuse LBCL; ECOG, European Cooperative Oncology Group; HGBCL, high-grade BCL; PMBCL, primary mediastinal BCL; SCT, stem cell transplant; TFL, transformed follicular lymphoma; UNL, upper normal limit.